Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg once daily vs. placebo in patients with Interstitial Cystitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MediciNova

Criteria

Inclusion Criteria:

• Male or female ≥ 18 years of age with a diagnosis of moderate to severe IC;

• Bladder pain ≥ 6 months prior to baseline;

• Urinary frequency of ≥ 8 ≤ 30 micturitions within 24 hours while awake;

• Nocturia ≥ 2x/night;

• Males and females of child-bearing potential (not surgically sterile or post-menopausal) must be abstinent or agree to use an study-accepted contraceptive regimens throughout the study:

• Female patients of child bearing age must have a negative urine pregnancy test at screening;

• Must provide a signed informed consent.

Exclusion Criteria:

• Male or females < 18 years of age;

• Initiation of new IC medication ≤ 30 days prior to baseline;

• Treatment with Elmiron ≤ 120 days prior to baseline;

• Treatment with bladder hydro-distention ≤ 6 months prior to baseline;

• Treatment with intravesical therapy ≤ 60 days prior to baseline;

• History of previous procedure(s) (e.g., augmentation cytoplasty, cystectomy or cystolysis) that has affected bladder function;

• Active genital herpes or vaginitis ≤ 90 days prior to baseline;

• Urinary tract or prostatic infection ≤ 90 days prior to baseline;

• History of urethral diverticulum;

• History of bladder or ureteral calculi;

• History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis;

• History of bladder tumors;

• History of uterine, cervical, vaginal, prostatic or urethral cancer ≤ 5 years prior to baseline;

• Patient is currently pregnant, lactating or likely to become pregnant during the study;

• Participated in another clinical study with an investigational drug or device ≤ 30 days prior to baseline.